510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K931520Substantially Equivalent

Epstein-Barr Virus Vca (Igm) Recomb Immun Antibody

Mrl Diagnostics, Cypress CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K931520 is the FDA 510(k) clearance record for EPSTEIN-BARR VIRUS VCA (IGM) RECOMB IMMUN ANTIBODY, a class I device, cleared for Mrl Diagnostics on under FDA product code LJN (Antibody Igm, If, Epstein-Barr Virus). FDA records list 7 510(k) clearances for Mrl Diagnostics, from to . As of , FDA records show no recalls naming K931520.

Clearance record

Decision date
Received
(396 days to decision)
Product code
LJN Antibody Igm, If, Epstein-Barr Virus
Regulation
21 CFR 866.3235
Device class
Class I
Review panel
Microbiology
Applicant
Mrl Diagnostics 10703 Progress Way, Cypress CA
510(k) summary
Summary
Third party review
No

Clearances, product code LJN

Trailing 12 months

FDA records hold no clearances under product code LJN in the trailing twelve months.

FDA records show no clearances under product code LJN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LJN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260